SOURCE: Pronova BioPharma ASA

November 27, 2007 10:31 ET

Patent Court Ruling in Germany

LYSAKER, NORWAY--(Marketwire - November 27, 2007) - Pronova BioPharma ASA (OSE: PRON.OL) ("Pronova BioPharma" or the "Company") announces that the Federal Patent Court in Munich, Germany, has today issued a decision by which Pronova BioPharma's patent covering the Active Pharmaceutical Ingredient ("API") of Omacor has been declared invalid in Germany. This decision follows the nullity action brought by KD Pharma Bexbach GmbH ("KD Pharma") and Institute Biochimique SA ("IBSA") against Pronova BioPharma in June 2006.

Pronova BioPharma strongly opposes this decision and will appeal the ruling, a process which is expected to last for several years. The patent in suit expires in August 2009 and Pronova BioPharma believes that today's decision has minimal commercial implications for the Company. Today's announcement does not affect the Company's right to supply and sell Omacor in Germany.

Tomas Settevik, Chief Executive Officer of Pronova BioPharma, commented:

"We strongly disagree with today's decision by the Federal Patent Court in Germany and will appeal against the ruling. Our patents for the API of Omacor are robust and we will continue vigorously to defend these in the courts." The court decision is the result of a patent challenge (Patent DE 3926658 C2) by the producers of nutritional supplements based on omega-3, KD Pharma and IBSA. Neither KD Pharma nor IBSA has regulatory approval to sell or manufacture Omacor in Germany.

For further information, please contact:

| Solveig  Hellebust,   Vice  President   HR   & | +47 22 53 48 94  |
| Communications                                 |                  |
| Hilde Steineger, Head of IR                    | +47 48 00 42 40  |
| Tomas Settevik, CEO                            | +47 22 53 48 61  |
| Deborah Scott, Financial Dynamics              | +44 207 269 7110 |

About Pronova BioPharma

Pronova BioPharma is a global leader in the research, development and manufacture of marine-originated omega-3 derived pharmaceutical products. Pronova BioPharma's first commercialized product is branded as Omacor in a number of countries throughout Europe and Asia and as Lovaza in the United States. The product is manufactured at the Company's plant in Sandefjord, Norway using a unique and complex process.

Omacor/Lovaza is the first and only EU- and FDA-approved omega-3 derived prescription drug. The drug is prescribed as an adjunct to diet for the treatment of elevated levels of triglycerides in humans, a condition known as hypertriglyceridemia (HTG), a form of dyslipidemia (or disorder of lipid metabolism). Very high triglycerides have been linked to a number of cardiovascular diseases. Omacor is also approved in key European and certain Asian markets for the secondary prevention of post-myocardial infarction, or Post-MI, the period following the initial survival of a heart attack.

Omacor/Lovaza has been demonstrated in a number of clinical trials to be a potent triglyceride-lowering agent as a monotherapy. It has been documented to be efficacious, safe, and highly complementary to other lipid-lowering agents, such as statins, and can be used in concomitant treatment for mixed dyslipidemia. In addition, Pronova BioPharma is involved in various projects to develop Omacor/Lovaza in a number of cardiovascular indications, including as a combination therapy with statins for mixed dyslipidemia which management believe represents a major market opportunity for the Company.

Pronova BioPharma's global network of license and distribution partners includes: Reliant Pharmaceuticals (US), Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (UK, Germany and others). The combined sales force from this network focused on the sale of Omacor/Lovaza is over 1,750 sales representatives, of which approximately 600 are employed by Reliant Pharmaceuticals in the US.

Omacor/Lovaza was launched in 2005 in the US and in major European markets, such as France and Spain. IMS Health reports that global end-user sales of the product have increased from US$144 million in 2005 to US$306 million in 2006. The current annual run rate for end-user sales is estimated at US$500 million, and the Company estimates that approximately 600,000 patients are currently on a prescription for Omacor/Lovaza.

Pronova BioPharma is listed at Oslo Børs. See for more information.

Copyright © Hugin ASA 2007. All rights reserved.

Contact Information

  • Contacts:
    Solveig Hellebust
    Vice President HR & Communications
    +47 22 53 48 94

    Hilde Steineger
    Head of IR
    +47 48 00 42 40

    Tomas Settevik
    +47 22 53 48 61

    Deborah Scott
    Financial Dynamics
    +44 207 269 7110